ClearanceBrief
Panels › Clinical Chemistry › Product code JIF · Class 1

Enzymatic Method, Ammonia

Regulation 862.1065

0510(k)s in 12 months (30 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
Get daily alerts for JIFSample briefCSV

Top companies in JIF

Company510(k)sRecalls
Siemens Healthcare Diagnostics25
Abbott Laboratories30
Beckman Coulter, Inc.21
Diagnostic Chemicals , Ltd.30
Randox Laboratories, Ltd.12
Bayer Diagnostics Corp.20
Em Diagnostic Systems, Inc.20
Sentinel Ch. Srl11
American Dade10
Baxter Healthcare Corp10
DateFirm and productCodeLinked 510(k)
Jul 30, 2020RANDOX LABORATORIES, LTD.
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Terminated		 JIFK030873
Jul 30, 2020RANDOX LABORATORIES, LTD.
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Terminated		 JIFK030873
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Terminated		 JIFK123677
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Terminated		 JIFK123320
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratori
Terminated		 JIFK023841
Jan 23, 2017Sekisui Diagnostics P.E.I. Inc.
Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
Terminated		 JIFK033921
Dec 16, 2016Siemens Healthcare Diagnostics, Inc.
Dimension Vista Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chem
Terminated		 JIFK123320
Dec 16, 2016Siemens Healthcare Diagnostics, Inc.
Dimension Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry
Terminated		 JIFK123320
Oct 26, 2015Sentinel CH SpA
Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
Terminated		 JIFK051114
Apr 16, 2012Beckman Coulter Inc.
SYNCHRON Ammonia (AMM) Reagent Product Usage: AMM reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Ammonia Calibrators, is intended for
Terminated		 JIFK984402
Oct 4, 2007Thermo Fisher Scientific
Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
Terminated		 JIFK974620

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.